Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

Drexel University

Status: Completed

Conditions: Surgical Procedures, Operative

Treatments: Device: fNIR light emitting and sensing device

Study type: Interventional

Funder types: Other

Identifiers

NCT00448877

16618

Details and patient eligibility

About

The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure.

After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who will have surgery
• 18-80 years old
• No restrictions on gender, race, or religion

Exclusion criteria

• Head and face surgery
• Induced hypotension
• Profound anemia
• Scar/tattoo on forehead
• Prior history of frontal lobe surgery
• Hemoglobinopathies
• Patients not undergoing general anesthesia
• Surgeries in the prone position
• Allergy to adhesive tape

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)